OncoMatch/Clinical Trials/NCT06521554
A Study of NVL-330 in Patients With Advanced or Metastatic HER2-altered NSCLC (HEROEX-1)
Is NCT06521554 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies NVL-330 for locally advanced solid tumor.
Treatment: NVL-330 — Phase 1a/1b dose escalation and expansion study designed to evaluate the safety and tolerability of NVL-330, determine the recommended Phase 2 dose (RP2D), and evaluate the antitumor activity in participants with advanced or metastatic human epidermal growth factor receptor 2 (HER2) -altered non-small lung cancer (NSCLC). Phase 1a dose escalation is designed to assess the safety and tolerability of NVL-330 and to select the candidate RP2D(s) and, if applicable, the MTD. Phase 1b expansion is designed to further evaluate the overall safety and tolerability of the candidate RP2D(s) of NVL-330 and to determine the RP2D of NVL-330 in participants with advanced or metastatic HER2 mutant NSCLC.
Check if I qualifyExtracted eligibility criteria
Cancer type
Tumor Agnostic
Biomarker criteria
Required: HER2 (ERBB2) oncogenic mutation
Documented oncogenic HER2 mutation such as HER2 exon20 insertion mutations or single nucleotide variants
Required: HER2 (ERBB2) exon20 insertion
Documented oncogenic HER2 mutation such as HER2 exon20 insertion mutations
Required: HER2 (ERBB2) single nucleotide variant
Documented oncogenic HER2 mutation such as HER2 exon20 insertion mutations or single nucleotide variants
Required: HER2 (ERBB2) amplification
Documented HER2 amplification
Prior therapy
Cannot have received: anticancer therapy
Ongoing or recent anticancer therapy
Lab requirements
Blood counts
bone marrow reserve
Kidney function
Liver function
Adequate organ function and bone marrow reserve
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- City of Hope - Lennar · Irvine, California
- University of California, Davis Comprehensive Cancer Center · Sacramento, California
- Stanford Cancer Institute · Stanford, California
- Sarah Cannon Research Institute at HealthONE · Denver, Colorado
- Georgetown University Medical Center · Washington D.C., District of Columbia
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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